PharmPK Discussion - USFDA form no.1571

On 14 Nov 2007 at 10:15:39, mohammed muhiyideen (mmuhiyideen.-a-.yahoo.com) sent the message

dear all,we would like to a bioequivalence study of cytotoxic drug on cancerpatients.do we have to submit form no.1571 of USFDA for this studybecause of its BIO-IND category?then who should fill this form?sponsoror principal investigator?usually we submit form no.1572.is not it? please clarify.

On 14 Nov 2007 at 16:31:43, Frank Bales (frankbales.at.msn.com) sent the message

Muhiyideen,

From the FDA web site:Form FDA 1572: is a form that is completed by each investigator priorto participating in an investigational new drug study. This formshould be updated during the course of an investigation if anyinformation on the form changes.Form FDA 1571: It is the responsibility of a sponsor to complete theform FDA 1571. However, if the investigator is the IND holder, she/hewould have to assume the sponsor's responsibility, and thereforecomplete the form.Instructions for completing the 1571 and 1572 can be found athttp://www.fda.gov/cder/forms/1571-1572-help.htmlThe actual forms can be found athttp://www.fda.gov/opacom/morechoices/fdaforms/cder.html.